Trial Outcomes & Findings for Antiplatelet Effects of Tirofiban vs. Cangrelor N-STEMI Patients Undergoing Percutaneous Coronary Intervention (NCT NCT03048019)

NCT ID: NCT03048019

Last Updated: 2023-12-11

Results Overview

Assessment of platelet aggregation (%) in response to 10uM thrombin receptor activator peptide. Normal reference range is 60-100% aggregation.

• Recruitment status: TERMINATED
• Target enrollment: 10 participants
• Primary outcome timeframe: 30 minutes post-start of the infusion
• Results posted on: 2023-12-11

Participant Flow

28 participants were enrolled. 18 participants were screen failures as they did not require coronary stenting. 10 participants were assigned treatment.

Participant milestones

Measure	Tirofiban Therapy patients randomized to tirofiban therapy Tirofiban: Patients will receive Tirofiban during the PCI procedure	Cangrelor Therapy patients randomized to cangrelor therapy Cangrelor: Patients will receive Cangrelor during the PCI procedure
Overall Study STARTED	5	5
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Tirofiban Therapy patients randomized to tirofiban therapy Tirofiban: Patients will receive Tirofiban during the PCI procedure	Cangrelor Therapy patients randomized to cangrelor therapy Cangrelor: Patients will receive Cangrelor during the PCI procedure
Overall Study Adverse Event	1	0

Baseline Characteristics

Antiplatelet Effects of Tirofiban vs. Cangrelor N-STEMI Patients Undergoing Percutaneous Coronary Intervention

Baseline characteristics by cohort

Measure	Tirofiban Therapy n=5 Participants patients randomized to tirofiban therapy Tirofiban: Patients will receive Tirofiban during the PCI procedure	Cangrelor Therapy n=5 Participants patients randomized to cangrelor therapy Cangrelor: Patients will receive Cangrelor during the PCI procedure	Total n=10 Participants Total of all reporting groups
Age, Continuous	57.0 years STANDARD_DEVIATION 12.1 • n=5 Participants	57.3 years STANDARD_DEVIATION 12.2 • n=7 Participants	57.3 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes post-start of the infusion

Assessment of platelet aggregation (%) in response to 10uM thrombin receptor activator peptide. Normal reference range is 60-100% aggregation.

Outcome measures

Measure	Tirofiban Therapy n=5 Participants patients randomized to tirofiban therapy Tirofiban: Patients will receive Tirofiban during the PCI procedure	Cangrelor Therapy n=5 Participants patients randomized to cangrelor therapy Cangrelor: Patients will receive Cangrelor during the PCI procedure
Thrombin Receptor Activator Peptide (TRAP) Induced Platelet Aggregation (%)	42.5 % aggregation Standard Deviation 10.2	71.2 % aggregation Standard Deviation 6.9

SECONDARY outcome

Timeframe: 30 minutes post-start of the infusion

Assessment of platelet aggregation (%) in response to 20uM ADP at baseline and serially following tirofiban or cangrelor infusion. Normal reference range is 60-100% aggregation.

Outcome measures

Measure	Tirofiban Therapy n=5 Participants patients randomized to tirofiban therapy Tirofiban: Patients will receive Tirofiban during the PCI procedure	Cangrelor Therapy n=5 Participants patients randomized to cangrelor therapy Cangrelor: Patients will receive Cangrelor during the PCI procedure
Adenosine Diphosphate (ADP) Induced Platelet Aggregation (%)	3.3 % aggregation Standard Deviation 3.1	39.4 % aggregation Standard Deviation 13.1

SECONDARY outcome

Timeframe: 30 minutes post-start of the infusion

Assessment of thrombin induced platelet-fibrin clot strength (mm) by thromboelastography (TEG6S). Normal reference range is 55-68 mm

Outcome measures

Measure	Tirofiban Therapy n=5 Participants patients randomized to tirofiban therapy Tirofiban: Patients will receive Tirofiban during the PCI procedure	Cangrelor Therapy n=5 Participants patients randomized to cangrelor therapy Cangrelor: Patients will receive Cangrelor during the PCI procedure
Thrombin Induced Platelet-fibrin Clot Strength (mm)	63.9 mm Standard Deviation 2.7	62.3 mm Standard Deviation 3.6

SECONDARY outcome

Timeframe: 30 minutes after the end of the infusion.

Real time evaluation of shear-induced thrombus formation using novel RUO T-TAS plus system. AUC is calculated as time to reach 60 kPa

Outcome measures

Measure	Tirofiban Therapy n=5 Participants patients randomized to tirofiban therapy Tirofiban: Patients will receive Tirofiban during the PCI procedure	Cangrelor Therapy n=5 Participants patients randomized to cangrelor therapy Cangrelor: Patients will receive Cangrelor during the PCI procedure
Shear-induced Thrombus Formation (AUC)	14.1 kPa*min Standard Deviation 13.7	1004 kPa*min Standard Deviation 884

Adverse Events

Tirofiban Therapy

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Cangrelor Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tirofiban Therapy n=5 participants at risk patients randomized to tirofiban therapy Tirofiban: Patients will receive Tirofiban during the PCI procedure	Cangrelor Therapy n=5 participants at risk patients randomized to cangrelor therapy Cangrelor: Patients will receive Cangrelor during the PCI procedure
Surgical and medical procedures Bleeding	20.0% 1/5 • Number of events 1 • Up to 48 hours after discharge	0.00% 0/5 • Up to 48 hours after discharge

Other adverse events

Measure	Tirofiban Therapy n=5 participants at risk patients randomized to tirofiban therapy Tirofiban: Patients will receive Tirofiban during the PCI procedure	Cangrelor Therapy n=5 participants at risk patients randomized to cangrelor therapy Cangrelor: Patients will receive Cangrelor during the PCI procedure
Nervous system disorders Paresthesia	0.00% 0/5 • Up to 48 hours after discharge	20.0% 1/5 • Number of events 1 • Up to 48 hours after discharge

Additional Information

Director of Clinical Trials

Sinai Center for Thrombosis Research

Phone: 443-244-1497

Email: kbliden@lifebridgehealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60